Cited by 356Retinal Diseases and TreatmentsRetinal and Macular SurgeryOcular Diseases and Behçet’s Syndrome

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HORIZON: An Open-Label Extension Trial of Ranibizumab for Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Singer, Michael A., Awh, Carl C., Sadda, SriniVas, Freeman, William R., Antoszyk, Andrew N., Wong, Pamela, Tuomi, Lisa·2012·Ophthalmology

DOI 10.1016/j.ophtha.2011.12.016

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Abstract

Objective To evaluate the long-term safety and efficacy of multiple intravitreal ranibizumab injections (Lucentis, Genentech, Inc., South San Francisco, CA) administered at the investigator's discretion in patients with choroidal neovascularization secondary to age-related macular degeneration.Design An open-label, multicenter, extension study.Participants Patients who completed the controlled treatment phase of 1 of 3 prospective, randomized, 2-year clinical trials of ranibizumab were eligible for enrollment. Analyses were performed for 3 groups: (1) patients treated with ranibizumab in the initial study (ranibizumab treated-initial; n = 600); (2) patients randomized to control who crossed over to receive ranibizumab (ranibizumab treated-XO; n = 190); and (3) ranibizumab-naïve patients (ranibizumab untreated; n = 63).Methods Ranibizumab 0.5 mg was administered at the investigator's discretion. Adverse events (AEs) and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) assessments were conducted at study visits every 3 to 6 months.Main outcome measures Incidence and severity of AEs.Results There was 1 occurrence of mild endophthalmitis per 3552 HORIZON injections in the ranibizumab treated-initial/ranibizumab treated-XO groups. There were no serious AE reports of lens damage, retinal tears, or rhegmatogenous retinal detachments in the study eyes. The proportion of patients with any single postdose intraocular pressure ≥30 mmHg was 9.2%, 6.6%, and 0%, and the proportion of patients with glaucoma was 3.2%, 4.2%, and 3.2% in the ranibizumab treated-initial, ranibizumab treated-XO, and ranibizumab untreated groups, respectively. Cataract AEs were less frequent in the ranibizumab untreated group: 6.3% versus 12.5% and 12.1% in the ranibizumab treated-initial and ranibizumab treated-XO groups, respectively. The proportion of patients with arterial thromboembolic events as defined by the Antiplatelet Trialists' Collaboration was 5.3% in the ranibizumab treated-initial and ranibizumab treated-XO groups, and 3.2% in the ranibizumab untreated group. At month 48 (2 years of HORIZON), the mean change in BCVA (ETDRS letters) relative to the initial study baseline was 2.0 in the ranibizumab treated-initial group versus -11.8 in the pooled ranibizumab treated-XO and ranibizumab untreated groups.Conclusions Multiple ranibizumab injections were well tolerated for ≥4 years. With less frequent follow-up leading to less treatment, there was an incremental decline of the visual acuity (VA) gains achieved with monthly treatment.Financial disclosure(s) Proprietary or commercial disclosure may be found after the references.

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Self-citation
Management of neovascular age-related macular degeneration: current state-of-the-art care for optimizing visual outcomes and therapies in development
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Authors: Singer, M. A., Awh, C. C., Sadda, S., Freeman, W. R., Antoszyk, A. N., Wong, P., & Tuomi, L.
Affiliations: Medical Center Ophthalmology Associates (US)
Tennessee Retina (US)
Doheny Eye Institute (US)
University of California San Diego (US)
Charlotte Eye Ear Nose & Throat Associates (US)
Genentech (US)
Corresponding author: Singer, Michael A.
ORCID: Singer, Michael A.
Awh, Carl C.
Sadda, SriniVas
Freeman, William R.
Wong, Pamela
Venue: Ophthalmology
Publisher: Elsevier BV
Published: 2012-06
Volume: 119
Issue: 6
Pages: 1175-1183
ISSN: 0161-6420 (ISSN-L)
DOI: 10.1016/j.ophtha.2011.12.016
OpenAlex: W2011393181
Cited by: 356
References: 14
Citations by year: 2026: 6 · 2025: 9 · 2024: 17 · 2023: 10 · 2022: 24 · 2021: 27 · 2020: 37 · 2019: 32 · 2018: 23 · 2017: 34 · 2016: 30 · 2015: 31 · 2014: 36 · 2013: 29 · 2012: 10
FWCI: 31.69
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Ophthalmology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
Health Sciences › Medicine › Ophthalmology › Retinal and Macular Surgery
Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
Keywords: ranibizumab, choroidal neovascularization, age-related macular degeneration, intravitreal injection, long-term safety, adverse events, endophthalmitis, intraocular pressure, glaucoma, cataract, visual acuity, anti-VEGF therapy, HORIZON trial, lens damage, retinal tears, retinal detachment
MeSH terms: Ranibizumab, Aged, Female, Follow-Up Studies, Humans, Macular Degeneration, Male, Visual Acuity, Treatment Outcome, Choroidal Neovascularization, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Intravitreal Injections, Antibodies, Monoclonal, Humanized

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HORIZON: An Open-Label Extension Trial of Ranibizumab for Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

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